06/10/2025
The last 1% that decides release timelines
Trace ionic contaminants are the silent bottleneck in many API campaigns. They pass through capture and intermediate clean-up steps, they confuse assays, and they trigger QC holds that delay release by days or weeks. If you are seeing unexpected reworks, extra polishing passes, or ppm-level failures, the problem is not sloppy analytics, it is the final polish. Ion exchange, applied as a targeted polishing step, is the practical fix.
What we do, in plain terms:
we place a tuned ion exchange column after your main purification and conditioning steps, we control pH and conductivity to an operational window that favors your API, and we run a programmed salt gradient to elute impurities separately from the product. The result: charged traces and counter-ions are removed to regulatory targets, your sterile filter sees a clean feed, and QC waits collapse.
Why this matters to your bottom line:
• Faster approvals, faster shipments, more predictable batch timing: less time spent on rework and retesting.
• Higher effective yield: keep more product in the finished batch, reduce cost per gram.
• Lower consumables spend: fewer polishing cycles, longer resin life, less buffer used.
• Cleaner submissions: tighter impurity profiles make regulatory reviews smoother.
Get in touch:
📧: info@sanitech-engineers.com
🌐: www.sanitech-engineers.com
📞 +91-22-6907-5151
Note: "Recovery rates and processing improvements are representative of typical applications and will vary based on molecule type, starting material quality, target purity specifications, buffer systems, and operating conditions. Individual results require validation through process development with your specific protein or peptide."
